Good Doctoring: Use of eXciteOSA in the dental office

’”I’m still snoring – should I move the mouthpiece out further?” – How many times have you heard this in your practice? What can you say?

New to the United States is a novel device to affect tongue posture from the inside out. eXciteOSA uses electrical stimulation, which has been shown to convert skeletal muscle fast-twitch fibers into slow-twitch high-endurance fibers, to keep the tongue forward in the mouth and the airway open. To get some insight into how this is being used in dental practices, DSP talked with three experienced dentists who focus their practices on sleepy people, facial pain, and TMD thaerapy.

Aditi Desai, BDS, from London, UK; Max Kerr, DDS, from Austin; and Kent Smith, DDS, of Dallas have each been using eXciteOSA in their practices since the first days the device became available for dentists.

DSP: What interested you in this new device? What made you think it would be helpful for your patients?

Max Kerr (MK): Patients are always coming in asking ‘what else can I do’ – I recall from your course, Kent, you showed us a digeridoo and talked about circular breathing. I understood about improving muscle tone from that. When I got an alert on my Google desktop about Signifier’s FDA authorization, I wanted to see how it could fit into our practice. Like a jazz artist, I wanted to have more instruments to play – see what fits into that patient’s groove.

Aditi Desai (AD): I was excited about this product right from the start, getting involved as soon as I could. In the UK, the device went by the name ‘SnooZeal’ at first – that’s how long I’ve been using it. I’m the President of the British Society of Dental Sleep Medicine, so I get a lot of calls about new innovations. One of my ENT colleagues had been trialing this device in the UK, and he contacted me as the company was looking to introduce it to a dentist. I agreed to meet with the company representatives. Within a couple of hours, I met the CEO, Akhil Tripathi – and it was then that I realized how many medical and scientific leaders in sleep medicine were involved. This all happened just a few days before we went into COVID lockdown.

Kent Smith (KS): At Sleep Dallas, we are always trying to find modalities to help people sleep. Sometimes appliances don’t work, patients don’t have any teeth, sometimes AHI gets better but not enough better. I follow a sleep doctor I heard at AASM meeting – I don’t treat the polysomnogram. I embraced this pretty quickly because it is something that has some backbone to it, there was research, I thought it was worth pursuing.

DSP: Kent, you mentioned edentulous patients. Together with people using clear aligners, those have been two populations that are very challenging and frustrating for therapy. CPAP, yes, but for intolerant patients, have you found eXciteOSA helpful?

KS: For edentulous patients, they can use it with or without their dentures – I just tell them to put it in. They want help, and nothing else has worked so far.

MK: It’s not mentioned in the FDA regulations, not a contraindication, so I say ‘just get it done.’

KS: I’ve never found an oral appliance I can use with clear aligners – there’s just nothing that works well. I think excite is a good option for those who won’t use CPAP while they are getting their teeth straightened.

MK: I tried a few of the devices over clear aligners, but they are a mess. This is much better.

AD: I have been able to manage a few patients who are either completing orthodontic treatment or who are undergoing extensive dental rehabilitation prior to having oral appliance therapy while unable to tolerate CPAP.

DSP: How do you choose the patients for which you want to prescribe eXciteOSA?

KS: People come in looking for it because they’ve heard about it, or they might see it in our clinic. If they ask about it, my team knows what to say. I sometimes use it for mild OSA or simple snorers, but not as first line for moderate or severe patients.

MK: If a person seems not likely to be a responder in Oral Appliance Therapy, I’m already thinking about it. I try to let patients choose which therapy they think will work for them. I tell patients what I know about the literature, the scientific studies. I wish I had as much as we do for OAT. When a patient is leaning toward eXciteOSA, and they have a more severe diagnosis, I don’t discourage it, but I let them know that it might not be sufficient and other therapy might be needed. This isn’t different than what I say for OAT for this life-threatening disease. I cite the literature, but I also keep in mind the reason many people aren’t getting their sleep apnea treated is how difficult the treatment is.

AD: I’ve seen a lot of patients with a tongue base issue – high BMI, big floppy tongue. I can’t always manage them with a MAD only. If they’re not going to be CPAP compliant, I thought it would be an adjunct to MAD and CPAP. I actually don’t pay much attention to severity – AHI is on its way out. I now treat any patient who needs help no matter what the severity – some improvement in their symptoms is better than none. If we limit ourselves to one particular therapy for severe apnoeacs for example, we are not serving our patients well.

DSP: After doing this for a while, what would you say to a dentist who is fairly new at this? How would eXciteOSA help them?

KS: if they’ve not done a lot of devices, they probably don’t have the verbal skills and office systems down yet to cover the cost factor. They can offer eXciteOSA as a cheaper option to keep the patient involved.

MK: A dentist who feels unprepared for side effects of dental appliances, such as an open bite, may want to provide just this therapy and if it doesn’t work, they can find a more experienced dental sleep medicine doctor to refer for OAT.

AD: I have an interesting case – a fairly high-profile person was referred to me. He didn’t have OSA, so the ENT consultant suggested he get a boil-in-a-bag device many years ago. It stopped working for him, and he had developed quite a significant bite change. I went ahead with a MAD and suggested eXciteOSA. About three weeks later when I saw him to fit his MAD, he reported that his snoring had reduced significantly, and his wife was much happier. I went ahead with the MAD anyway, because I had confidence in it. About six months later at the follow up visit, he reported that he was not wearing the MAD, because his snoring had stopped, and all the bite changes were reversed. It’s only one case, but it made me and the patient very happy. So for MAD patients who have had bite changes, why not use eXciteOSA and see if it helps enough? That’s one case – it’s not something I count on, but it seems helpful. There are others who have reported snoring cessation or much reduced levels of snoring decibels.

DSP: Have you had any negative feedback from patients? Signifier offers a guarantee if it “doesn’t work.” What’s been your experience?

AD: I’ve prescribed 65 or 70 of the devices, and recently we were able to do an audit of about 40 of them. A few complained of mild pain from having to hold the device in the mouth, but they needed to be shown not to bite too hard on the mouthpiece. One woman couldn’t get over excessive salivation, another blamed it on making his tinnitus worse, but those two are the only ones who have returned their devices. So I don’t have much to say about negative side effects.

KS: Other than patients who say “It didn’t work,” just like we hear with mandibular advancement, the only other negative feedback came from a patient whose cardiologist told him to stop wearing it. More education is needed.

MK: At the highest levels, some patients have reported transient discomfort with eXciteOSA. Other than that, the only feedback that I have received has been regarding compliance. Some patients have difficulty keeping up with the treatment schedule.

DSP: How do you handle the cost factor?

AD: These are not within the NHS. We occasionally help with payment plans when the need arises, but I just let the patient choose. The guarantee helps, and not having to charge VAT if the patient certifies they have OSA and not just snoring.

MK: It will be great if insurance would start paying for it, but until then, we have the patients pay cash. The price varies whether they are getting a MAD to go with it, we bundle the replacement mouthpieces, and any other thing we can do to maximize patient outcomes. Retail is not any significant factor in Sleep Better Austin, anyway, so we don’t make it a barrier if the patient chooses this therapy.

KS: Same here. Sometimes we even give it away if seems to be the right thing for the patient. Maybe that’s not the best for business, but like Max, retail isn’t our thing – it’s creating the right therapy plan for that patient.

DSP: There are some codes for this therapy, K1028 and K1029, but reimbursement is mixed from private payors, so far. HSA accounts can be used.

Thank you all, for a very interesting conversation! I know readers of DSP are always looking for ways to help – and having another non-invasive, easy to use therapy might just be the right answer for the patient in your chair.